PMA P250020

Device
Belotero Volume (+) Lidocaine
Applicant
Merz North America, Inc.
PMA number
P250020
Product code
LMH
Decision date
2026-05-19
Classification
General, Plastic Surgery
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for deep (subcutaneous and/or supraperiosteal) injection to improve volume deficit in the mid-face or to correct mid-face contour deficiencies in adults 22 years or older

Current openFDA PMA Record#

Device
Belotero Volume (+) Lidocaine
Applicant
Merz North America, Inc.
PMA number
P250020
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2026-05-19
Decision code
APPR
Date received
2025-06-26
Approval order statement
Approval for deep (subcutaneous and/or supraperiosteal) injection to improve volume deficit in the mid-face or to correct mid-face contour deficiencies in adults 22 years or older